Maker of Popular Children’s Pain Relievers Agrees to $25 Million Fine for Selling Contaminated Medicines

As parents, we scrutinize everything we put into and onto our children from the time they are born, so it is quite upsetting to learn that a trusted and widely-used children’s over-the-counter pain medicine continued to be sold by the “family” company that knew for a year their medicine was contaminated with metal particles.

McNeil Consumer Healthcare (“McNeil”), a subsidiary of “the family company,” Johnson & Johnson, maker of Infants & Children’s Tylenol and Children’s Motrin, recently agreed to pay a $25 million fine to settle federal criminal charges it continued selling its popular children’s medicines knowing they contained metal particles, and pleaded guilty to failing to take immediate corrective action once the particles were discovered, instead continuing to sell the contaminated medicine for a year before ordering a recall. McNeil also agreed to FDA inspections and increased oversight of its quality control measures.

McNeil first learned of possible contamination in May 2009 after consumer complaints about “black particles” in its Infants’ Tylenol, but did nothing to alert consumers or recall the contaminated medicines, instead choosing to continue selling that and other contaminated medicines for a full year until it issued its first recall of millions of bottles in May 2010.

An FDA investigation discovered McNeil’s Fort Washington, Pennsylvania plant, was the source of the contamination. FDA inspectors found the plant was dirty and lacked quality control standards, and traced the metal particles found in the contaminated children’s medicines to machinery at the plant. The plant was temporarily closed for “upgrades” in June 2010, but has never reopened.

Thankfully, no injuries have been reported to the FDA or McNeil, but McNeil’s conduct seems even more egregious since their products are made for infants and children. In this case, McNeil obviously chose money over children’s safety, jeopardizing the health of millions by continuing to sell known contaminated medicines for a year before ordering a recall. Acting Assistant Attorney General Benjamin Mizer outlined the government’s position on this type of corporate behavior, explaining, “The Department of Justice will continue to be aggressive in pursuing and punishing companies such as McNeil that disregard a process designed to assure quality medicines, especially OTC drugs for infants and children.” We hope the government is committed to protecting consumer safety because it is painfully obvious corporations will always choose profits over people, even the most innocent and vulnerable in our society, and greedy corporate behavior will only change when the bottom line bottoms out.